Effects of 12-week dairy-derived nutritional supplementation combined with physical activity on health and physical function in healthy middle aged women after a 2-week period of reduced activity

Not Applicable

Completed

• Conditions: Physical health; Bone health; Mental health; Physical function; Musculoskeletal - Normal musculoskeletal and cartilage development and function; Metabolic and Endocrine - Normal metabolism and endocrine development and function; Diet and Nutrition - Other diet and nutrition disorders

• Registration Number: ACTRN12616001714471
• Lead Sponsor: Anthony Blazevich

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-12-14
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

1.age = 40-60 y
2.Female
3.BMI (18 -35 kg/m2)
4.Sedentary to moderately active
5.Healthy

Exclusion Criteria

1.Previous negative reaction to milk or dairy proteins
2.Previous negative reaction to fish
3.Currently perform structured physical activity in their occupation
4.Baseline protein above 1.2 g/kg/day
5.Calcium intake of > 750 mg/day
6.Alcohol > 14 drinks per week (average)
7.Smoking (or only having stopped smoking within the last 2 years)
8.T-score bone mineral density (BMD) at either the hip or lumbar spine < -2.5
9.Have any fixations (i.e. spine or femoral rods, hip replacements)
10.Irregular menstrual cycle (not within 20-35 days); lack of cycle is not a criterion
11.Using hormone replacement therapy
12.Planning to become pregnant or currently breastfeeding
13.Using supplements such as vitamin D (>400 IU), calcium, bone/joint assistants (glucosamine, chondroitin), or antacids containing calcium carbonate, and not willing to stop for at least 6 weeks prior to, and throughout, the duration of the trial.
14.Anti-inflammatory use (including aspirin, ibuprofen, omega 3)
15. Rheumatoid arthritis
16.Use of beta blockers or ACE inhibitors
17.Metabolic bone disease (including osteoporosis, osteomalacia, osteogenesis imperfect and Paget’s disease)
18.Endocrine disorders (including hyper- or hypo-thyroidism, parathyroid disease, diabetes mellitus and Cushing’s syndrome)
19.Cancer (including cervical, ovarian, uterine, breast, liver and of the gastrointestinal system)
20.Other medical conditions impacting on digestion, including diseases of the gastrointestinal tract, or previous operations such as gastrectomy or intestinal resection, or the liver (i.e. cirrhosis).
21.Any chronic muscle disease, disorder or injury
22.Asthma that is not controlled or other respiratory diseases
23.Self-reported personal or family history of deep vein thrombosis or similar clotting disorders

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Ascending<br>The participant will be instructed to walk or run as quickly as possible up 11 stairs each 16 cm high, without missing a step. The participant will start at the base of the stairs with both feet together and then ascend the stairs on the ‘go’ command of the experimenter. Timing will commence when the participant makes their first movement and will stop when both feet are placed on the final step. Two trials will be recorded to the nearest 0.01, and reported to the nearest 0.1 s, with 1 min of rest between (including slow stair descent).<br><br>The fastest stair ascent time will be taken as stair climb performance. Additionally, stair climb power for the 11-step test will be measured using the equation: Power (watts) = 9.81 × body mass (kg) × vertical height (m) / time (s).<br>[0, 2, 5, 8, 11, 14 weeks of trial; i.e. before and after the 2-week Phase 1 and 12-week Phase 2 arms, as well as at 3, 6 and 9 weeks during Phase 2 (mid-training testing).]